The purpose of this study is to determine whether providing high dose glutamine and antioxidants to critically ill patients will be associated with improved survival.

Condition	Intervention	Phase
Critical Illness Sepsis Organ Failure Hypopertfusion	Drug: Glutamine and Antioxidants	Phase III

Further Study Details: 

Primary Outcomes: The primary outcome for this study is 28-day mortality.
Secondary Outcomes: The secondary outcomes are duration of stay in ICU, adjudicated diagnosis of infection, multiple organ dysfunction, duration of mechanical ventilation, hospital length of stay, and health-related quality of life at 3 and 6 months.
Expected Total Enrollment:  1200

Background : Critically ill patients experience a degree of hyperinflammation, cellular immune dysfunction, and oxidative stress. Supplementation with key nutrients, like glutamine and antioxidants, is most likely to have a favourable effect on these physiological parameters leading to an improvement in clinical outcomes. The results of two separate meta-analyses suggested that glutamine and antioxidants may be associated with improved survival. We have recently completed a dosing study to determine the maximal tolerable dose (MTD) of glutamine dipeptides and antioxidants in critically ill patients with evidence of hypoperfusion. The purpose of this protocol is to evaluate the effect of high dose glutamine and antioxidant supplementation on mortality in a large scale randomized trial.

Study Intervention : Patients will be randomized to receive glutamine supplementation or antioxidant supplementation (or respective placebo).

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Mechanically ventilated patients > or = 18 yrs old
• 2 or more organ failures related to their acute illness

Exclusion Criteria:

• > 24 hours from admission to ICU
• Patients who are moribund
• Lack of commitment to aggressive care
• Absolute contraindication to enteral nutrients
• Severe acquired brain injury
• Routine elective cardiac surgery
• Primary admission of burns> 30 % body surface area
• Weight < 50 kgms or > 200 kgms
• Pregnant or lactating patients
• Previous randomization in this study
• Enrollment in a related ICU interventional study
• Child''''s class C liver disease
• Metastatic Cancer with life expectancy < 6 months
• Seizure disorder requiring anticonvulsant medication

Please refer to this study by ClinicalTrials.gov identifier  NCT00133978

Daren Heyland, MD      613-549-6666  Ext. 3339    dkh2@post.queensu.ca
John Muscedere, MD      613-549-6666  Ext. 4642    muscedej@kgh.kari.net

Canada, Ontario
      Kingston General Hospital, Kingston,  Ontario,  K7L 2V7,  Canada; Recruiting

Study chairs or principal investigators

Daren Heyland, MD,  Study Chair,  Clinical Evaluation Research Unit, Kingston General Hospital.   

Study ID Numbers:  RDX-001
Last Updated:  August 23, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00133978
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-30